Liver Transplant SurgeryNCT06606184
Benefits of Pulmonary Rehabilitation to Patients Post Liver Transplant
A study testing Inspiratory muscle Training and Routine Care in people with Liver Transplant Surgery, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The goal of this clinical trial was to access the benefits of a 12-week home-based pulmonary rehabilitation regimen on pulmonary function recovery in post-liver transplant patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Transplant Surgery
- What is being tested?
- Inspiratory muscle Training and Routine Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 years or older
- Scheduled to undergo living donor liver transplantation
- Stable vital signs
- Normal cognitive function
- Able to perform activities independently using their own strength and coordination
- Willing and able to participate in 12 weeks of rehabilitation training
Who cannot join
- Severe physical illness during the operation
- Acute bleeding
- Unstable vital signs
- Hepatic encephalopathy, or neurological conditions such as stroke, Parkinson\'s disease, or cognitive dysfunction
- Limited mobility (e.g., unable to stand, lift upper limbs, or bedridden)
- Inability to comply with 12 weeks of pulmonary rehabilitation post-discharge
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- Unstable vital signs
- Hepatoencephalopathy, such as cardiovascular accident, Parkinson disease, cognitive dysfunction
- Those with limited mobility (unable to stand, unable to lift upper limbs, or bedridden)
- Those who are unable to cooperate with the 12 weeks of pulmonary rehabilitation exercises after discharge.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial was to access the benefits of a 12-week home-based pulmonary rehabilitation regimen on pulmonary function recovery in post-liver transplant patients. The main questions it aims to answer are:
Does pulmonary rehabilitation facilitate pulmonary muscle strength recovery? Does the intervention improve pulmonary function and reduce dyspnea sensation?
Participants performed:
Inspiratory muscle training twice a day for 12 weeks after discharged from the hospital Upper limb resistive training Lower limb exercise
Read the detailed description
Patients undergoing liver transplantation often face significant challenges related to pulmonary rehabilitation. Although postoperative rehabilitation has been extensively studied, the specific role of pulmonary rehabilitation programs has received limited attention. This study aims to evaluate the efficacy of a home-based pulmonary rehabilitation program in improving respiratory function recovery among post-liver transplant patients. The training group participated in a 12-week pulmonary rehabilitation program post-discharge, emphasizing respiratory muscle and exercise training, while the control group received standard care, which included traditional rehabilitation.
- Conditions
- Liver Transplant Surgery
- Being tested
- Inspiratory muscle Training, Routine Care
- Keywords
- liver transplant, pulmonary rehabilitation, inspiratory muscle training, inspiratory muscle strength, Dyspnea
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle TrainingProcedure or surgery
Participants underwent a 12-week program consisting of inspiratory muscle training twice daily, incentive spirometry three times daily, and upper limb exercises along with marching in place for 30 minutes.
Routine CareProcedure or surgery
Participants received routine care, which included encouragement to use incentive spirometry three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training group | Experimental | Participants received a 12-week inspiratory muscle training and incentive spirometry therapy after discharged from hospital Receives: Procedure: Inspiratory muscle Training |
| Routine care | Sham comparator | Participants received incentive spirometry therapy only Receives: Procedure: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Stregnth Test
Respiratory muscle strength was determined by Maximum Inspiratory Pressure (MIP) using a pressure monometer.
Measured: Throughout the study completion, approximately 3 month
Secondary outcomes (3)
Oxygenation status
Oxygen saturation was monitored using a pulse oximeter.
Measured: Participants underwent maximum inspiratory and expiratory pressure measurements at four time points: upon admission, before discharge from the intensive care unit, before discharge from the hospital, and at the end of the 12-week enrollment period.
Dyspnea Severity Assessment
Dyspnea severity was assessed by a rating of perceived exertion, using the Borg Scale which ranged from 0 (no respiratory difficulty) to 10 (extreme respiratory difficulty), with higher scores indicating more severe breathing difficulty.
Measured: Throughout the study completion, approximately 3 month
Forced Vital Capacity
The forced vital capacity was obtained, using spirometry, by having the patient take a deep breath and then exhale forcefully. The test results were based on three reproducible measurements.
Measured: Throughout the study completion, approximately 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University of Science and Technology, Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Hui-Ling Lin, Chang Gung University
- Investigators
- Jui-Fang Lin, PhD, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606184
- Sponsor's protocol ID
- 202102058B0
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data is available upon request from the principal investigator.
Publications
Au KP, Chan SC, Chok KS, Sharr WW, Dai WC, Sin SL, Wong TC, Lo CM. Clinical factors affecting rejection rates in liver transplantation. Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):367-73. doi: 10.1016/s1499-3872(15)60391-5.
PubMed 26256080Aamir,T., Iftikhar,S., Khan, R.R., &Khan, M.K (2019).Role of physiotherapy in improving quality Of life in liver transpant patients. The Rehabilitation Journal, 3(2),126-130.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Pulmonary Rehabilitation to Patients Post Liver Transplant
- ClinicalTrials.gov ID
- NCT06606184
- Acronym / sponsor ID
- 202102058B0
- Conditions
- Liver Transplant Surgery
- Keywords
- liver transplant, pulmonary rehabilitation, inspiratory muscle training, inspiratory muscle strength, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung University of Science and Technology, Chang Gung Memorial Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial was to access the benefits of a 12-week home-based pulmonary rehabilitation regimen on pulmonary function recovery in post-liver transplant patients. The main questions it aims to answer are:
Does pulmonary rehabilitation facilitate pulmonary muscle strength recovery? Does the intervention improve pulmonary function and reduce dyspnea sensation?
Participants performed:
Inspiratory muscle training twice a day for 12 weeks after discharged from the hospital Upper limb resistive training Lower limb exercise
Detailed description
Patients undergoing liver transplantation often face significant challenges related to pulmonary rehabilitation. Although postoperative rehabilitation has been extensively studied, the specific role of pulmonary rehabilitation programs has received limited attention. This study aims to evaluate the efficacy of a home-based pulmonary rehabilitation program in improving respiratory function recovery among post-liver transplant patients. The training group participated in a 12-week pulmonary rehabilitation program post-discharge, emphasizing respiratory muscle and exercise training, while the control group received standard care, which included traditional rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training group | Experimental | Procedure: Inspiratory muscle TrainingParticipants received a 12-week inspiratory muscle training and incentive spirometry therapy after discharged from hospital |
| Routine care | Sham comparator | Procedure: Routine CareParticipants received incentive spirometry therapy only |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 20 years or older
- Scheduled to undergo living donor liver transplantation
- Stable vital signs
- Normal cognitive function
- Able to perform activities independently using their own strength and coordination
Key exclusion criteria (10 listed)
- Severe physical illness during the operation
- Acute bleeding
- Unstable vital signs
- Hepatic encephalopathy, or neurological conditions such as stroke, Parkinson\'s disease, or cognitive dysfunction
- Limited mobility (e.g., unable to stand, lift upper limbs, or bedridden)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle TrainingParticipants underwent a 12-week program consisting of inspiratory muscle training twice daily, incentive spirometry three times daily, and upper limb exercises along with marching in place for 30 minutes. | Procedure or surgery | Inspiratory Muscle Training group |
| Routine CareParticipants received routine care, which included encouragement to use incentive spirometry three times daily. | Procedure or surgery | Routine care |
Primary outcome
Respiratory Muscle Stregnth Test
Time frame: Throughout the study completion, approximately 3 month
Respiratory muscle strength was determined by Maximum Inspiratory Pressure (MIP) using a pressure monometer.
3 secondary outcomes
Oxygenation status
Time frame: Participants underwent maximum inspiratory and expiratory pressure measurements at four time points: upon admission, before discharge from the intensive care unit, before discharge from the hospital, and at the end of the 12-week enrollment period.
Dyspnea Severity Assessment
Time frame: Throughout the study completion, approximately 3 month
Forced Vital Capacity
Time frame: Throughout the study completion, approximately 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 26256080Au KP, Chan SC, Chok KS, Sharr WW, Dai WC, Sin SL, Wong TC, Lo CM. Clinical factors affecting rejection rates in liver transplantation. Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):367-73. doi: 10.1016/s1499-3872(15)60391-5.
- BackgroundAamir,T., Iftikhar,S., Khan, R.R., &Khan, M.K (2019).Role of physiotherapy in improving quality Of life in liver transpant patients. The Rehabilitation Journal, 3(2),126-130.
- Individual participant dataSharing planned: Yes. The data is available upon request from the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jui-Fang Lin, PhD principal investigator
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle Training and Routine Care in people with Liver Transplant Surgery, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Stregnth Test (time frame: Throughout the study completion, approximately 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606184, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.